Cited by 2,575Multiple Myeloma Research and TreatmentsBone health and treatmentsChronic Lymphocytic Leukemia Research

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Antitumor Activity of Thalidomide in Refractory Multiple Myeloma

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Singhal, Seema, Mehta, Jayesh, Desikan, Raman, Ayers, Dan, Roberson, Paula, Eddlemon, Paul, Munshi, Nikhil, Anaissie, Elias, Wilson, Carla, Dhodapkar, Madhav, Zeldis, Jerome, Siegel, David, Crowley, John, Barlogie, Bart·1999·New England Journal of Medicine

DOI 10.1056/nejm199911183412102

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Abstract

BACKGROUND: Patients with myeloma who relapse after high-dose chemotherapy have few therapeutic options. Since increased bone marrow vascularity imparts a poor prognosis in myeloma, we evaluated the efficacy of thalidomide, which has antiangiogenic properties, in patients with refractory disease. METHODS: Eighty-four previously treated patients with refractory myeloma (76 with a relapse after high-dose chemotherapy) received oral thalidomide as a single agent for a median of 80 days (range, 2 to 465). The starting dose was 200 mg daily, and the dose was increased by 200 mg every two weeks until it reached 800 mg per day. Response was assessed on the basis of a reduction of the myeloma protein in serum or Bence Jones protein in urine that lasted for at least six weeks. RESULTS: The serum or urine levels of paraprotein were reduced by at least 90 percent in eight patients (two had a complete remission), at least 75 percent in six patients, at least 50 percent in seven patients, and at least 25 percent in six patients, for a total rate of response of 32 percent. Reductions in the paraprotein levels were apparent within two months in 78 percent of the patients with a response and were associated with decreased numbers of plasma cells in bone marrow and increased hemoglobin levels. The microvascular density of bone marrow did not change significantly in patients with a response. At least one third of the patients had mild or moderate constipation, weakness or fatigue, or somnolence. More severe adverse effects were infrequent (occurring in less than 10 percent of patients), and hematologic effects were rare. As of the most recent follow-up, 36 patients had died (30 with no response and 6 with a response). After 12 months of follow-up, Kaplan-Meier estimates of the mean (+/-SE) rates of event-free survival and overall survival for all patients were 22+/-5 percent and 58+/-5 percent, respectively. CONCLUSIONS: Thalidomide is active against advanced myeloma. It can induce marked and durable responses in some patients with multiple myeloma, including those who relapse after high-dose chemotherapy.

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Authors: Singhal, S., Mehta, J., Desikan, R., Ayers, D., Roberson, P., Eddlemon, P., Munshi, N., Anaissie, E., Wilson, C., Dhodapkar, M., Zeldis, J., Siegel, D., Crowley, J., & Barlogie, B.
Affiliations: University of South Carolina (US)
University of Arkansas for Medical Sciences (US)
Rockefeller University (US)
ORCID: Singhal, Seema
Desikan, Raman
Roberson, Paula
Munshi, Nikhil
Dhodapkar, Madhav
Zeldis, Jerome
Siegel, David
Barlogie, Bart
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1999-11-18
Volume: 341
Issue: 21
Pages: 1565-1571
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm199911183412102
OpenAlex: W2316160054
Cited by: 2,575
References: 35
Citations by year: 2026: 27 · 2025: 41 · 2024: 48 · 2023: 48 · 2022: 69 · 2021: 73 · 2020: 62 · 2019: 67 · 2018: 56 · 2017: 62 · 2016: 69 · 2015: 75 · 2014: 76 · 2013: 102 · 2012: 89
FWCI: 69.79
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute (P01CA055819, CA-55819)
Topics: Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
Health Sciences › Medicine › Oncology › Bone health and treatments
Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
Keywords: thalidomide, multiple myeloma, refractory multiple myeloma, anti-angiogenic therapy, Bence Jones protein, microvessel density, event-free survival, overall survival, adverse effects
MeSH terms: Bence Jones Protein, Bone Marrow, Bone Marrow Examination, Drug Administration Schedule, Female, Humans, Male, Microcirculation, Middle Aged, Multiple Myeloma, Myeloma Proteins, Recurrence, Remission Induction, Thalidomide, Multivariate Analysis, Survival Analysis, Disease Progression, Angiogenesis Inhibitors

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Antitumor Activity of Thalidomide in Refractory Multiple Myeloma

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